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Trial record 13 of 36 for:    AMINOCAPROIC ACID

Tranexamic Acid (TXA) Versus Epsilon Aminocaproic Acid (EACA) Versus Placebo for Spine Surgery

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ClinicalTrials.gov Identifier: NCT00958581
Recruitment Status : Completed
First Posted : August 13, 2009
Results First Posted : December 12, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Scoliosis
Interventions Drug: Tranexamic Acid
Drug: Normal Saline
Drug: Epsilon aminocaproic acid
Enrollment 177
Recruitment Details Consenting completed at PI and co-investigators' private offices, clinic and in preoperative center. Study staff approved by the IRB consent the patients. First patient enrolled on 12/16/2008. Last patient enrolled on 9/17/2012.
Pre-assignment Details Patients were excluded from the trial after enrollment if their surgery was cancelled.
Arm/Group Title Epsilon Aminocaproic Acid Normal Saline Tranexamic Acid
Hide Arm/Group Description

Patients will receive EACA before and during the surgical case.

Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.

Patients infused with normal saline before and during the surgical procedure as a placebo.

Normal Saline :

Patients receive TXA before and during the surgical case.

Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr.

Period Title: Overall Study
Started 61 61 55
Completed 61 61 55
Not Completed 0 0 0
Arm/Group Title Epsilon Aminocaproic Acid Normal Saline Tranexamic Acid Total
Hide Arm/Group Description

Patients will receive EACA before and during the surgical case.

Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.

Patients infused with normal saline before and during the surgical procedure as a placebo.

Normal Saline :

Patients receive TXA before and during the surgical case.

Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr.

Total of all reporting groups
Overall Number of Baseline Participants 61 61 55 177
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 55 participants 177 participants
<=18 years
42
  68.9%
47
  77.0%
36
  65.5%
125
  70.6%
Between 18 and 65 years
15
  24.6%
12
  19.7%
11
  20.0%
38
  21.5%
>=65 years
4
   6.6%
2
   3.3%
8
  14.5%
14
   7.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 55 participants 177 participants
Female
50
  82.0%
39
  63.9%
45
  81.8%
134
  75.7%
Male
11
  18.0%
22
  36.1%
10
  18.2%
43
  24.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 61 participants 61 participants 55 participants 177 participants
61
 100.0%
61
 100.0%
55
 100.0%
177
 100.0%
1.Primary Outcome
Title Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)
Hide Description [Not Specified]
Time Frame 1 Week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epsilon Aminocaproic Acid Normal Saline Tranexamic Acid
Hide Arm/Group Description:

Patients will receive EACA before and during the surgical case.

Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.

Patients infused with normal saline before and during the surgical procedure as a placebo.

Normal Saline :

Patients receive TXA before and during the surgical case.

Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr.

Overall Number of Participants Analyzed 61 61 55
Mean (Standard Deviation)
Unit of Measure: ml
1775  (853) 2116  (1201) 1531  (911)
2.Secondary Outcome
Title Total Units of Autologous and Allogenic Transfusion (Both Intraoperatively and Postoperatively Until Discharge)
Hide Description [Not Specified]
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure unattainable as PI and study team are no longer with the institution. This outcome measure data was not published in paper.
Arm/Group Title Normal Saline Tranexamic Acid Epsilon Aminocaproic Acid
Hide Arm/Group Description:

Patients infused with normal saline before and during the surgical procedure as a placebo.

Normal Saline: Normal saline of same volume as the intervention group will be given as the intervention group as a loading dose and maintenance dose.

Patients receive TXA before and during the surgical case.

Tranexamic Acid: For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr.

Patients will receive EACA before and during the surgical case.

Epsilon aminocaproic acid: For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Length of Hospital Stay From Admission Until Patient Discharge
Hide Description [Not Specified]
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure unattainable as PI and study team are no longer with the institution. This outcome measure data was not published in paper.
Arm/Group Title Normal Saline Tranexamic Acid Epsilon Aminocaproic Acid
Hide Arm/Group Description:

Patients infused with normal saline before and during the surgical procedure as a placebo.

Normal Saline: Normal saline of same volume as the intervention group will be given as the intervention group as a loading dose and maintenance dose.

Patients receive TXA before and during the surgical case.

Tranexamic Acid: For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr.

Patients will receive EACA before and during the surgical case.

Epsilon aminocaproic acid: For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Epsilon Aminocaproic Acid Normal Saline Tranexamic Acid
Hide Arm/Group Description

Patients will receive EACA before and during the surgical case.

Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.

Patients infused with normal saline before and during the surgical procedure as a placebo.

Normal Saline :

Patients receive TXA before and during the surgical case.

Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr.

All-Cause Mortality
Epsilon Aminocaproic Acid Normal Saline Tranexamic Acid
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Epsilon Aminocaproic Acid Normal Saline Tranexamic Acid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/61 (1.64%)      1/61 (1.64%)      1/55 (1.82%)    
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism   1/61 (1.64%)  1 1/61 (1.64%)  1 1/55 (1.82%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Epsilon Aminocaproic Acid Normal Saline Tranexamic Acid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/61 (0.00%)      0/61 (0.00%)      0/55 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Thomas Errico (Chief of Spine), Dr. Kushagra Verma (Co-investigator)
Organization: NYU hospital for Joint Diseases
Phone: 212-598-6076
EMail: thomas.errico@nyumc.org; vermak01@gmail.com
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00958581     History of Changes
Other Study ID Numbers: 08-779
First Submitted: August 11, 2009
First Posted: August 13, 2009
Results First Submitted: November 14, 2017
Results First Posted: December 12, 2017
Last Update Posted: January 17, 2018